Last reviewed · How we verify
A Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Determine the Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in Spinal Cord Injury
The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.
Details
| Lead sponsor | US Department of Veterans Affairs |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2007-04 |
| Completion | 2014-12 |
Conditions
- Spinal Cord Injury
Interventions
- extended release beta-2 adrenergic agonist
- placebo
Primary outcomes
- Inspiratory Respiratory Muscle Strength — Outcome will be measured at baseline, prior to intervention, and after 12 weeks of twice daily drug treatment.
Respiratory muscle strength as measured by maximal inspiratory and pressures at the mouth.
Countries
United States